OncoMatch/Clinical Trials/NCT06990880
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
Is NCT06990880 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GSK5458514 for neoplasms, prostate.
Treatment: GSK5458514 — The goal of the study is to evaluate how safe and how well the body handles GSK5458514 when administered in participants with prostate cancer. The study will be conducted in two parts - Part 1 (dose escalation phase) and Part 2 (dose expansion phase).
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: FOLH1 expression
retrospective detection of Prostate-specific membrane antigen (PSMA) expression and other biomarker analysis
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: antiandrogen — novel anti-androgen receptor therapy
Has prior novel anti-androgen receptor therapy failure
Must have received: taxane
had treatment failure with 1-2 taxane-based chemotherapy regimens including for metastatic hormone sensitive prostate cancer
Cannot have received: PSMA radionuclide therapy
Exception: unless participant received <2 cycles
Prior PSMA radionuclide therapy within 2 months prior to GSK5458514 unless participant received <2 cycles
Cannot have received: PSMA CAR-T cell therapy
Prior PSMA-Chimeric antigen receptor T cell therapy (CAR-T) cell therapy
Cannot have received: PSMA T cell engager
PSMA (T cell engager) TCE/ Bispecific T cell engagers (BiTE) or other prostate Tumor-associated antigens (TAA) specific T cell engager (TCE)
Cannot have received: bone marrow transplant
any history of prior allogenic or autologous bone marrow transplant
Cannot have received: solid organ transplant
other solid organ transplant
Cannot have received: systemic biologic therapy
Any anti-cancer therapy or prior systemic biologic therapy, including immunotherapy within 4 weeks of start dose
Lab requirements
Liver function
ALT ≤2.5x ULN or ≤5x ULN if documented history of liver metastases; total bilirubin ≤1.5x ULN; no cirrhosis or current unstable liver or biliary disease
Has an Alanine aminotransferase (ALT) value >2.5x upper limit of normal (ULN) or >5x ULN if documented history of liver metastases. Has a total bilirubin value >1.5x ULN. Has cirrhosis or current unstable liver or biliary disease per investigator assessment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- GSK Investigational Site · Denver, Colorado
- GSK Investigational Site · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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